R&D Systems Hematology Controls and Calibrators has completed the Class B Certification under the new European Union In Vitro Diagnostic Regulation
This press release updates the IVDR Classification to Class B from the prior Class C.
MINNEAPOLIS, Nov. 11, 2024 -- Bio-Techne Corporation (NASDAQ: TECH) has recently achieved In Vitro Diagnostic Regulation (IVDR) certification for its R&D Systems Hematology Controls and Calibrators. This certification confirms that the products comply with the regulations and guidelines set forth by the European Union for in-vitro diagnostic devices.
This IVDR certification demonstrates the product's exceptional quality standards, ensuring high levels of accuracy, precision, and reliability. It marks an important milestone in Bio-Techne's commitment to meeting the needs of healthcare professionals.
Hematology Controls and Calibrators are essential components in the laboratory setting that support accuracy in patient testing. With the IVDR certification, customers can be assured that Bio-Techne's R&D Systems Hematology Controls and Calibrators meet the rigorous standards required in hematology.
"At Bio-Techne, we take pride in designing and manufacturing products that enable researchers and healthcare professionals to improve patients' lives. We are thrilled to be able to offer IVDR certified Hematology Controls and Calibrators to our customers, ensuring they receive the highest quality products," said Dr. Matt McManus, President of Bio-Techne's Diagnostics & Spatial Biology Segment.
About Bio-Techne Corporation
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing.
For more information on Bio-Techne and its brands, please visit https://www.bio- techne.com or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube.
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